Efficacy Study of FES Controlled by Electromyographic Signal for the Treatment of Upper Limb in Post-stroke Patients
NCT ID: NCT03019744
Last Updated: 2018-10-26
Study Results
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View full resultsBasic Information
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COMPLETED
NA
82 participants
INTERVENTIONAL
2011-04-30
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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MeCFES
25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation
MeCFES-assisted task-oriented upper limb rehabilitation
Control
25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation
Usual Care task-oriented upper limb rehabilitation
Interventions
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MeCFES-assisted task-oriented upper limb rehabilitation
Usual Care task-oriented upper limb rehabilitation
Eligibility Criteria
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Inclusion Criteria
* at least 1 month post-stroke
* willingness to participate the project
* minimum voluntary muscle activation of shoulder flexors (\>1 Manual Muscle Test)
* passive Range of Motion (ROM) of the shoulder and elbow of more than 90°
Exclusion Criteria
* severe spasticity at upper limb (\>= 3 Ashworth scale)
* implanted electronic device
* respiratory insufficiency
* pregnancy
* peripheral neuropathies
* cutaneous ulcers at the stimulation zone
* other use of FES on the upper limb
18 Years
ALL
No
Sponsors
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Istituto Di Ricerche Farmacologiche Mario Negri
OTHER
Fondazione Don Carlo Gnocchi Onlus
OTHER
Responsible Party
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Maurizio Ferrarin
Dr.Eng., Ph.D.
Principal Investigators
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Maurizio Ferrarin, PhD
Role: PRINCIPAL_INVESTIGATOR
Fondazione Don Carlo Gnocchi Onlus
References
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van der Lee JH, Roorda LD, Beckerman H, Lankhorst GJ, Bouter LM. Improving the Action Research Arm test: a unidimensional hierarchical scale. Clin Rehabil. 2002 Sep;16(6):646-53. doi: 10.1191/0269215502cr534oa.
Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
Wessels R, de Witte L, Andrich R, Ferrario M, Persson J, Oberg B, Oortwijn W, VanBeekum T, Lorentsen Ã. IPPA, a user-centered approach to assess effectiveness of assistive technology provision. Technol Disabil. 2000;13:105-15
Kennedy CA, Beaton DE, Solway S, McConnell S, Bombardier C. Disabilities of the Arm, Shoulder and Hand (DASH). The DASH and QuickDASH Outcome Measure User's Manual, Third Edition. Toronto, Ontario: Institute for Work & Health, 2011.
Other Identifiers
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RISES
Identifier Type: -
Identifier Source: org_study_id
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